Viaskin Peanut for Peanut Allergy

(VITESSE Trial)

Not currently recruiting at 91 trial locations

Overseen By DBV Technologies

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: DBV Technologies

Must not be taking: Immunotherapy, Biologics

Disqualifiers: Severe dermatologic disease, Uncontrolled asthma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DBV712, delivered through a patch, to determine if it can reduce peanut sensitivity in children. The main goal is to assess whether applying this patch daily for 12 months can safely lessen allergic reactions in children aged 4 to 7 with a peanut allergy. Participants will receive either the active treatment or a placebo (a patch with no active ingredients) for comparison. This trial may suit children with a doctor-confirmed peanut allergy who follow a strict peanut-free diet. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on immunotherapy for any allergen or have used certain treatments like monoclonal antibodies within 6 months before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the peanut patch, DBV712, is generally safe for daily use. Studies have found that children aged 4 to 7 with peanut allergies usually tolerate the patch well. Most side effects were mild, such as skin reactions at the application site, while serious side effects were rare. The peanut patch has undergone extensive testing and demonstrated positive safety results compared to a placebo (a treatment with no active ingredient). This suggests the patch is a safe option for children with peanut allergies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peanut allergy?

Unlike standard peanut allergy treatments, which often rely on avoidance and emergency epinephrine, Viaskin Peanut (DBV712) offers a novel approach by using an epicutaneous patch. This patch allows for the gradual introduction of peanut proteins through the skin, potentially increasing tolerance without the need for oral ingestion, which can be risky for those with severe allergies. Researchers are excited because this method could provide a safer, more convenient way to manage peanut allergies and improve quality of life for those affected.

What evidence suggests that DBV712 might be an effective treatment for peanut allergy?

In this trial, participants will receive either the DBV712 peanut patch or a placebo. Research has shown that the DBV712 peanut patch can help children with peanut allergies become less sensitive to peanuts. Studies have found that the patch reduces allergic reactions more effectively than a placebo, making it a promising option for children aged 1 to 7 years. Long-term use, such as 36 months, can enhance its effectiveness. Most children can use the patch without serious side effects, indicating it is generally safe. Overall, these findings support the peanut patch as a safe and effective way to help children manage their peanut allergies. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for peanut-allergic children aged 4-7 who react to a very small amount of peanut protein and are on a strict peanut-free diet. They must have certain levels of peanut-specific antibodies and skin test reactions. Kids with uncontrolled asthma, past immunotherapy for peanuts, or recent biologic treatments can't join.

Inclusion Criteria

Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet

Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1

I am between 4 and 7 years old.

Exclusion Criteria

I have severe skin disease on my upper back.

My asthma symptoms are not well-controlled.

I have received or am receiving immunotherapy for peanut allergy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Participants receive daily DBV712 250 mcg or placebo for 12 months to assess efficacy and safety in inducing desensitization to peanut

12 months

Monthly visits (in-person)

Open-label Extension

Participants apply DBV712 250 mcg daily for an additional 24 or 36 months, depending on initial randomization, to continue treatment and assess sustained unresponsiveness

24-36 months

Annual visits (in-person)

Follow-up

Participants are monitored for sustained unresponsiveness through open food challenges at 2, 4, and 6 months off treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• DBV712
• Placebo

Trial Overview The study tests the safety and effectiveness of DBV712 (250 mcg), a daily treatment aimed at desensitizing children to peanuts over one year. The comparison is made against a placebo—a substance with no active drug—to see if DBV712 makes any difference.

How Is the Trial Designed?

Group I: Open Label Extension Period: DBV712 250 mcg Experimental Treatment 1 Intervention

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36).

Group II: DBPC Treatment Period: DBV712 250 mcg Experimental Treatment 1 Intervention

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Group III: DBPC Treatment Period: Placebo Placebo Group 1 Intervention

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Who Is Running the Clinical Trial?

DBV Technologies

Lead Sponsor

Trials

17

Recruited

3,500+

Citations

1. aaaai.org aaaai.org/about/news/news/2025/patch

Long term Use of Peanut Patch Shows Increased Benefit VIASKIN peanut patch is a well-tolerated treatment for children with peanut allergies according to research being presented at the 2025 AAAAI / WAO Joint ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05741476

NCT05741476 | Safety and Efficacy Study of Viaskin ... The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut- ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/1744666X.2024.2315221

Safety and efficacy of epicutaneous immunotherapy with ... Overall, the results from these studies have demonstrated the peanut patch to be superior in desensitization compared with placebo and safe for daily use over ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212895

Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers ... In this phase 3 trial, treatment with a peanut patch was superior to placebo in desensitizing children 1 to 3 years of age with peanut allergy, ...

5. dbv-technologies.com dbv-technologies.com/press_releases/dbv-technologies-announces-positive-3-year-results-from-epitope-phase-3-open-label-extension-study/

DBV Technologies Announces Positive 3-Year Results ... The data provide support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters.

6. dbv-technologies.com dbv-technologies.com/pipeline/viaskin-peanut/

VIASKIN® peanut patch This study is evaluating an investigational drug patch called DBV712 for 4 to 7 year old children with peanut allergy.

7. dbv-technologies.com dbv-technologies.com/press_releases/dbv-technologies-secures-agreement-with-fda-on-safety-exposure-data-required-for-bla-for-viaskin-peanut-patch-in-4-7-year-olds-accelerating-the-timeline-for-a-bla-filing-submission-to-1/

DBV Technologies Secures Agreement with FDA on Safety ... DBV Technologies secures agreement with FDA on safety exposure data required for biologics license application (BLA) for Viaskin Peanut Patch in 4–7-year-olds.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03211247

NCT03211247 | Safety and Efficacy Study of Viaskin ... The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age